WHAT IS GALENIQUE STUDIO? Galenique
Studio,
offered by PTI, Inc., ismodular and customizable software
that can be used as a tool by the pharmaceutical scientists working in the
area of analytical, pre-formulation, formulation and process development.

Galenique Studio
is consisted of a single module or combination of several modules. The
number, use, extend of customization, as well as the programming techniques
vary depending on the ultimate use of the software as well as the type
dosage form for which the system will be utilized. For example, module deals with troubleshooting the modern Film-Coating
Processes, and provides insight into the major film-coating problems that
plague the pharmaceutical industry today. Another module,
is a useful tool for predicting the weight, density and force variation for
a given formulation running at a specific, (i.e., clients’) bilayer tablet
press, as well as for training the pharmaceutical scientists in this area.

While each module
of Galenique Studio can be independently
used to meet the need of the client in a specific area of interest,
integration of several modules can turn Galenique
Studiointo a powerful expert system that can be utilized for the
purpose of recommending solutions, trouble shooting, training, etc., during
the development of pharmaceutical dosage forms.

Why would a pharmaceutical scientist
need a tool such as is Galenique Studio?
Preformulation studies represent the first step in the rational development
of all pharmaceutical dosage forms. It is a well known fact that
physico-chemical and mechanical properties of pharmaceutical materials
dictate how formulations will behave during manufacturing and ultimately
perform as a drug delivery system. Main objective of Preformulation studies
is to generate information on those properties that will be useful to
formulation scientists in developing stable, robust, and appropriately
bioavailable tablets that can ultimately be mass-produced. That is where
INFORMex, the most basic module of Galenique Studio becomes an
extremely useful tool for the pharmaceutical scientists.

It is also common
in formulation development studies that the formulation scientist may have
extensive knowledge of the active ingredients that are to be formulated (say
into a tablet form) and yet still needs to know which excipients to select,
and their proportions. At this stage, a knowledge based, so called “expert
system”, can be helpful to the scientist in selecting suitable excipients..
The outcome of the recommendations may heavily depend upon the drug release
properties of the final dosage form as specified by the scientist. Another
case where such an expert system could be off use in formulation studies is
the determination of the design space for manufacturing conditions.

During the
preformulation studies and subsequent formulation and process development
phases of a product, immense amount of data are collected and recorded
usually in the laboratory notebooks or computers. Unfortunately in many
cases no further subsequent utilization of these data and or the imbedded
knowledge is possible or practical unless some sort of data management tool
is used. That is where a modular form of Galenique Studio becomes an
indispensable tool.

Please note that we
also offer other customized expert systems such as Immediate
and Controlled Release Formulation Expert Systems, or Extended
Compaction Analysis Programs, as well!